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. 2026 Feb 25.
doi: 10.1253/circj.CJ-25-0791. Online ahead of print.

Ischemic and Bleeding Events After Early Initiation of Direct Oral Anticoagulants for Acute Intracranial Hemorrhage With Non-Valvular Atrial Fibrillation - A Multicenter Prospective Registry

Masatoshi Koga  1 , Kazunori Toyoda  1 , Yasuyuki Iguchi  2 , Ryo Itabashi  3 , Hiroharu Kataoka  4 , Michikazu Nakai  5 , Kanta Tanaka  1 , Kaori Miwa  1 , Rei Kondo  6 , Tatemi Todaka  7 , Naoto Kimura  8   9 , Kunikazu Yoshimura  10 , Shigeo Yamashiro  11 , Takahiro Ogishima  12 , Yuka Terasawa  13 , Nobukazu Komoribayashi  14 , Nobuyuki Sakai  15 , Taketo Hatano  16 , Shuji Arakawa  17 , Kazutaka Sonoda  18 , Joji Hagii  19 , Teruyuki Hirano  20 , Fumio Miyashita  21 , Hiroyuki Ohnishi  22 , Kazumi Kimura  23 , Toshihiro Ueda  24 , Keiko Maezono-Kandori  25 , Yukako Yazawa  26 , Masanori Kinosada  27 , Tsuyoshi Izumo  28 , Shouhei Noshiro  29 , Hikaru Nagasawa  30 , Kuniyasu Wada  31 , Hiroshi Yamagami  32   33 , Kenji Kamiyama  34 , Yasushi Takagi  35 , Yasuhiro Ito  36 , Kumiko Sugio  37 , Atsushi Takita  38 , Tetsuya Kimura  39 , Martin Unverdorben  40 , Masafumi Ihara  41 , Shigeru Fujimoto  42 , Ashkan Shoamanesh  43 ; SAFE-ICH Registry Group
Affiliations
Free article

Ischemic and Bleeding Events After Early Initiation of Direct Oral Anticoagulants for Acute Intracranial Hemorrhage With Non-Valvular Atrial Fibrillation - A Multicenter Prospective Registry

Masatoshi Koga et al. Circ J. .
Free article

Abstract

Background: The efficacy and safety of early direct oral anticoagulant (DOAC) (re)initiation in patients with non-valvular atrial fibrillation (NVAF) after acute onset of intracranial hemorrhage (ICH) are unknown. This study evaluated ischemic and hemorrhagic risks following early DOAC (re)initiation after ICH in patients with NVAF.

Methods and results: SAFE-ICH is a multicenter prospective observational single-arm registry study at 32 Japanese hospitals. Eligible patients had NVAF, were aged ≥20 years, and (re)initiated DOAC ≤14 days following symptomatic ICH. Among 240 patients who (re)initiated DOAC (61.3% male; mean [±SD] age 79.4±9.3 years), intraparenchymal hemorrhage predominated (84.6%), followed by subdural (12.9%), intraventricular (1.7%), and epidural (0.8%) hemorrhage. The median (interquartile range) baseline National Institutes of Health Stroke Scale score was 10 (3-16) and time to DOAC (re)initiation was 7 days (5-10 days). Edoxaban, apixaban, and rivaroxaban were used in 55.0%, 35.8%, and 9.2% of patients, respectively. The primary endpoint (composite of symptomatic ICH, any stroke, or death ≤30 days following DOAC [re]initiation) occurred in 12 (5.0%) patients. There were 4 recurrent ICH events (1.7%; all recurrent subdural hemorrhages). Five (2.1%) patients died of non-vascular causes.

Conclusions: In Japanese patients with NVAF, early DOAC (re)initiation ≤14 days after ICH appears to have an acceptable risk for ischemic and hemorrhagic events, particularly in patients with intraparenchymal hemorrhage. In patients with subdural hematoma, early DOAC (re)initiation requires vigilant monitoring.

Keywords: Anticoagulants; Ischemic stroke; Non-vitamin K antagonist oral anticoagulant; Oral anticoagulation; Stroke.

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